#HHSN268201100025C
MedaMACS
The Medical Arm of Mechanical
Circulatory Support
MedaMACS Operating Instructions
MOI Title:
Site Institutional Review Board or Ethics Board Approvals
(PUBLIC/COMPLETE)
Document Number:
MOI-17-004-V1
Document Storage Location:
M:\INTERMACS 2011-2015\17 MedaMACS\2 MOI Public\MOI-17-004-V1 Site Institutional Review Board
Approvals.docx
MOI Author:
Position:
Sharmene Smith
MedaMACS Program Manager
Approved by:
Position:
Sharmene Smith
MedaMACS Program Manager
Approved Date:
Effective Date:
Last Edited Date:
07/15/2013
07/15/2013
07/15/2013
Page 1 of 3
MOI-17-004-V1
Site Institutional Review Board Approvals
SITE INSTITUTIONAL REVIEW BOARD OR ETHICS BOARD APPROVALS
1. PURPOSE AND SCOPE
The purpose of this document is to describe the IRB application process for participating MEDAMACS
sites.
2. APPLICABLE REGULATION AND POLICIES
Each site must have Institutional Review Board (IRB) or Ethics Board (EB) approval to be an active
participating site in MEDAMACS. Once enrolled in MEDAMACS, sites are required to renew their IRB
or EB documents on an annual basis.
3. PERSONNEL / RESPONSIBILITIES
Site Administrator, responsible for interaction with the local IRB/EB and the MEDAMACS
Data Coordinating Center.
MEDAMACS Regulatory Director and Regulatory Manager, interact with the Site Administrator on
the MEDAMACS documents required for submission.
4. PROCEDURE
For initial site enrollment the site must submit an application for MEDAMACS participation to the
local Institutional Review Board or Ethics Board.
The following documents must be provided to the IRB or EB:
MEDAMACS Protocol
MEDAMACS Certificate of Confidentiality Approval Notice
Informed Consent Documents (adult and/or pediatric)
 Informed Consent for Participation
 HIPPA
 Patient Authorization for MEDAMACS to Release Information form
 Revoke Authorization
Note: Some institutions require submission of additional MEDAMACS documents such as the
MEDAMACS Data Coordinating Center IRB Approval, the MEDAMACS Users’ Guide, Printable
Forms or MEDAMACS Reports. Please follow the institutions guidelines.
Documentation of IRB/EB approval including supporting documents must be forwarded to
MEDAMACS Regulatory Director/Manager prior to activation.
For annual renewals the site must submit annual renewal documents to the local IRB/EB for
approval. Informed Consent documents must be approved annually.
Note: Please allow sufficient time to submit the annual renewal documents to the local IRB/EB
and provide the approval notice and approved consent documents to MEDAMACS prior to the
expiration of documents on file. Non-receipt of valid documents necessitates site inactivation.
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MOI-17-004-V1
Site Institutional Review Board Approvals
For amendments the site must submit an amendment application to the local IRB or EB. Guidance
will be provided by the MEDAMACS Regulatory Director/Manager at the time of the amendment
announcement.
Documentation of IRB/EB amendment approval including supporting documents must be forwarded
to the MEDAMACS Regulatory Director/Manager.
The MEDAMACS Regulatory Director/Manager is available to provide guidance on MEDAMACS
required submissions
5. DEFINITIONS
Institutional Review Board (IRB) or Ethics Board (EB) – An appropriately constituted group that has
been formally designated to review and monitor biomedical research involving human subjects.
HIPAA - Health Insurance Portability and Accountability Act
6. SUPPORTING DOCUMENTATION AND RESOURCES
MEDAMACS Regulatory Director/Manager may be contacted.
7. REVISION HISTORY
Record minor changes and additions to the IOI in the following table. Major changes require a new
version of the IOI (see iNTERMACS-IOI-03-001 Management of Standard Operating Procedures).
Revision
01
Author
Sharmene
Smith
Revisions Made
New IOI
Effective Date
07/15/2013
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